Ulotaront, a Trace Amine-Associated Receptor 1/Serotonin 5-HT

Area of Science:

• Neuroscience
• Psychiatry
• Pharmacology

Background:

• Ulotaront, a trace amine-associated receptor 1 agonist, is in Phase 3 for schizophrenia.
• Parkinson disease psychosis (PDP) requires effective and safe antipsychotic treatments.

Purpose of the Study:

• To explore the efficacy and safety of ulotaront for treating Parkinson disease psychosis (PDP).
• To evaluate ulotaront's impact on psychosis symptoms and motor function in PDP patients.

Main Methods:

• Randomized, double-blind, placebo-controlled pilot study.
• 38 patients with PDP received ulotaront (25, 50, or 75 mg/d) or placebo for 6 weeks.
• Primary endpoint: Change from baseline in Scale for the Assessment of Positive Symptoms for Parkinson Disease (SAPS-PD).

Main Results:

• Numerically reduced SAPS-PD scores in ulotaront group vs. placebo (LS mean difference -1.1; p=0.681).
• 25% of ulotaront-treated patients achieved complete remission of PDP symptoms.
• Improved sleepiness scores (p=0.022); no worsening of motor function or cognition.
• Adverse events included hallucinations and confusional state.

Conclusions:

• Ulotaront demonstrated a numerical reduction in PDP symptoms and improved sleepiness.
• The drug was generally well-tolerated, with no worsening of motor function.
• Further investigation is warranted, especially in patients with cognitive impairment.